The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.
Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ≥18 years of age receiving drugs of interest (DOIs) per standard of care (SOC), as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum. To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.
Study Type
OBSERVATIONAL
Enrollment
164
Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
Lamivudine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
Emtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
Botswana-UPenn Partnership
Botswana, Gaborone, South Africa
Lesirane Clinic
Botswana, Gaborone, South Africa
Mogoditshane Clinic KDC
Botswana, Gaborone, South Africa
Old Naledi Clinic
Botswana, Gaborone, South Africa
Drug concentration in maternal plasma
Drug concentration of a DOI in maternal plasma
Time frame: Baseline
Drug concentration in maternal breastmilk
Drug concentration of a DOI in maternal breastmilk
Time frame: Baseline
Drug concentration in infant plasma
Drug concentration of a DOI in infant plasma
Time frame: Baseline
Milk/Plasma ratio
The drug exposure of selected DOIs will be evaluated using milk/plasma ratio
Time frame: Baseline
Estimated daily infant dose
The drug exposure of selected DOIs will be evaluated using the estimated daily infant dose
Time frame: Baseline
Relative infant dose
The drug exposure of selected DOIs will be evaluated using relative infant dose
Time frame: Baseline
Infant/maternal exposure ratio
The drug exposure of selected DOIs will be evaluated using infant/maternal exposure ratio
Time frame: Baseline
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Tenofovir Disoproxil Fumarate will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.